Prenatal Cocaine and Neurobehavioral Factors Underlying Mother-Infant Interaction
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes
研究概览
简要总结
The purpose of the study is to understand the biology and behavior of early mother-infant attachment, and to investigate how it may be affected by prenatal substance exposures. The investigators are interested in how drugs such as cocaine, alcohol, marijuana and cigarette smoking affect both mother and baby.
详细描述
The investigators are looking for pregnant women or mothers with their newborn infants to participate in this study. Eligible women include mothers who have used any of the following drugs at any time during pregnancy (alone or in combination):
- cocaine
- nicotine (cigarettes)
- marijuana
- alcohol
The investigators are also looking for mothers who have not used any drugs during pregnancy.
Information collected in this research study is strictly confidential, and protection of sensitive information is additionally assured by an NIH Certificate of Confidentiality.
Participation in this study involves:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •During pregnancy, mother has used any of the following:
- •marijuana and/or alcohol but not cocaine
- •nicotine (smoked cigarettes)
- •no drugs during pregnancy
- •Mother is pregnant or no more than 4 weeks postpartum
排除标准
- •Mother has cardiovascular disease
- •Delivery before 36 weeks or later than 42 weeks gestation
- •Birth weight less than 5.5 lbs
- •Baby was a multiple birth
研究组 & 干预措施
Prenatal Cocaine
Use of cocaine at anytime during pregnancy. Subjects may also have used other drugs in combination with Cocaine
Prenatal Nicotine-Alcohol-Marijuana
Subjects may have used any of these drugs during pregnancy, alone or in combination. This group has not used cocaine during pregnancy.
Drug-Free Pregnancy
Subjects did not use any of the following drugs during pregnancy:
cocaine, nicotine, alcohol, marijuana.
结局指标
主要结局
Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes
时间窗: 2 to 4 weeks of age
次要结局
未报告次要终点